NCT02487706

Brief Summary

Data on the capacity of hemodialysis to remove dolutegravir (DTG) from plasma in patients with end-stage renal disease (ESRD) on hemodialysis (HD) are lacking. If DTG was removed from plasma by HD, it would be possible to have subtherapeutic drug concentrations at the end of HD sessions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4 hiv

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_4 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

1 month

First QC Date

June 29, 2015

Last Update Submit

September 30, 2015

Conditions

HIV

Keywords

HemodialysisHIV-infection

Outcome Measures

Primary Outcomes (2)

  • hemodialysis extraction ratio of dolutegravir

    Day 5

  • hemodialysis clearance of dolutegravir

    Day 5

Secondary Outcomes (1)

  • percentage of patients presenting adverse events related to dolutegravir

    From Baseline to day 5

Study Arms (1)

Dolutegravir 50mg/day per 5 days

EXPERIMENTAL

Dolutegravir 50mg/day per 5 days

Drug: Dolutegravir

Interventions

DolutegravirDRUG

Dolutegravir 50mg/day per 5 days

Dolutegravir 50mg/day per 5 days

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 1 years old or older.
  • HIV documented infection (western blot)
  • ESRD undergoing routine hemodialysis
  • Stable antiretroviral treatment (no changes within the prior 2 weeks)
  • Signature of informed consent

You may not qualify if:

  • Clinical evidence or suspicion that the patient will not be able to comply with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Related Publications (1)

  • Molto J, Graterol F, Miranda C, Khoo S, Bancu I, Amara A, Bonjoch A, Clotet B. Removal of Dolutegravir by Hemodialysis in HIV-Infected Patients with End-Stage Renal Disease. Antimicrob Agents Chemother. 2016 Mar 25;60(4):2564-6. doi: 10.1128/AAC.03131-15. Print 2016 Apr.

    PMID: 26856824DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

dolutegravir

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 1, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations

ES(1)